Recent Updates
Recently added Catalysts

BMS-833923

Phase 1

Stomach Neoplasms | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jun 21, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment39
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00909402A Study of BMS-833923 With Cisplatin and Capecitabine in Inoperable, Metastatic Gastric, Gastroesophageal, or Esophageal AdenocarcinomasPHASE1 COMPLETED 39 — — Nov 1, 2009Nov 1, 2012Jun 21, 20136 United States, Canada +2
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Use National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) to establish the MTD, Dose Limiting Toxicity (DLT(s)) and safety profile of BMS-833923 administered in combination with Cisplatin and Capecitabine
At a minimum on days 1, 8, 15 and 35 of cycle 1, days 1 & 14 for cycle 2 and every 21 days thereafter

MTD - maximum tolerated dose

Secondary Endpoints
To evaluate the safety of single-agent BMS-833923, by assessing the evaluation of number, character and duration of adverse event (AE)/serious adverse event (SAE)s
At a minimum on days 1, 8, 15 and 35 of cycle 1, days 1 & 14 for cycle 2 and every 21 days thereafter
Pharmacodynamic effects of BMS-833923 will be measured in tumor biopsy samples taken prior to and during single-agent and combination treatment by evaluation of protein or mRNA of biomarkers of Hedgehog (HH) pathway activation, such as GLI-1
During cycle 1
The pharmacokinetic parameters that will be assessed include: Cmax (Maximum observed plasma concentration)
During cycles 1, 2 & 3
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
All SubjectsEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-833923DRUGCapsule, Oral, Starting dose 30 mg, Once daily, continuous until discontinuation from study
CisplatinDRUGVial, intravenous (IV), 80 mg/m² IV, Once every 21 days, 1 day per cycle until discontinuation from study
CapecitabineDRUGTablets, Oral, 1000 mg/m², twice a day (BID), 14 days per cycle, until discontinuation from study
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation. Inclusion Criteria: * Esophageal, gastric, or gas...

Countries:United StatesCanadaFranceNetherlands
Unlock Eligibility Criteria